CAR-T Cells Targeting Autoimmune Diseases
CAR-T Cells Targeting B Cell Related Autoimmune Diseases
1 other identifier
interventional
30
1 country
2
Brief Summary
The purpose of this study is to assess the feasibility, safety and efficacy of CAR-T cell therapy in patients with autoimmune disease. Another goal of the study is to learn more about the safety and function of the CAR-T cells and their persistency in autoimmune disease patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jul 2022
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2022
CompletedFirst Posted
Study publicly available on registry
July 15, 2022
CompletedStudy Start
First participant enrolled
July 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedJuly 19, 2022
July 1, 2022
3 years
July 12, 2022
July 17, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety of 4SCAR T cells in patients with autoimmune diseases
Safety of 4SCAR T cells in patients with autoimmune diseases using CTCAE 5 standard to evaluate the level of adverse events
12 weeks
Secondary Outcomes (2)
B cell and immunoglobulin suppression activity of 4SCAR T cells in patients with autoimmune diseases
1 year
B cell and immunoglobulin suppression activity of 4SCAR T cells in patients with autoimmune diseases
1 year
Study Arms (1)
4SCAR T Cell Therapy for autoimmune diseases
EXPERIMENTALInterventions
Infusion of 4SCAR T cells at 10\^6 cells/kg body weight via IV
Eligibility Criteria
You may qualify if:
- age older than 18 years.
- expression of B cell surface molecules.
- the KPS score over 80 points, and survival time is more than 3 months.
- greater than Hgb 80 g/L.
- no contraindications to blood cell collection.
You may not qualify if:
- accompanied with other active diseases and difficult to assess treatment response.
- bacterial, fungal, or viral infection, unable to control.
- living with HIV.
- active HBV or HCV infection.
- pregnant and nursing mothers.
- under systemic steroid treatment within a week of the treatment.
- prior failed CAR-T treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, 518000, China
Guilin Hospital of Chinese Traditional and Western Medicine
Guilin, Guangxi, 541000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2022
First Posted
July 15, 2022
Study Start
July 31, 2022
Primary Completion
July 31, 2025
Study Completion (Estimated)
June 30, 2026
Last Updated
July 19, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share